Clinical trials in India generated $200 million in revenue in 2007 and are expected to reach $500 million by 2010. India currently holds 5% of the global clinical trials market but may reach 15% by 2011. In 2008, 65% of India's 536 clinical trials were Phase III. Low costs, disease prevalence, medical infrastructure, and quality standards are driving growth, but shortages of professionals, lack of data exclusivity, approval delays, and ethical issues pose challenges. The market is regulated by government agencies and growing competition exists among pharmaceutical companies and clinical research organizations conducting trials in India.
2. Executive Summary
Revenues from clinical trials were USD 200 mn in 2007; Expected to reach USD 500 mn by 2010
Market Total 536 clinical trials were conducted in India in 2008
India’s share in global clinical trial market in 2007 was 5% and is likely to reach 15% in 2011
65% f li i l t i l
65% of clinical trials conducted in India in 2008 were Phase III trials
d t d i I di i 2008 Ph III t i l
Drivers: Challenges:
Drivers & Cost competitiveness Shortage of research professionals
Disease prevalence in India
p Lack of data exclusivity
y
Challenges
Sound medical infrastructure Delays in trial approval
International quality standards Challenges of unethical trials
Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI)
Government Clinical trials are governed by Scheduled Y of Drugs and Cosmetics act and Indian Council of
Regulations Medical Research (ICMR) guidelines
Registration of trials involving humans has been made mandatory starting in June 2009 on the
Clinical Trials Registry‐India (CTRI) website
International pharmaceuticals companies are the major sponsors of clinical trials
Many Indian and foreign pharmaceutical companies have tied up with other specialist clinical
Competition research companies for development of new drugs
Internationally certified central laboratories and research institutes also conduct clinical trials in
India
Some of the leading CROs in India include Vimta Labs, Synchron, Reliance Clinical Research
CLINICAL TRIALS MARKET – INDIA.PPT 2
4. Clinical trial is the final step in drug development process after
preliminary laboratory research and animal testing
FDA Review Post
Pre‐clinical
Drug discovery Phase I Phase II Phase III and Marketing
Testing
Approval Testing
Clinical trials are research studies involving humans and take place in four different phases
Number of Participants Length Purpose
Phase 1
Phase 1 20‐80 Several months • Mainly safety
Phase 2
Phase 2 100‐300 Several months to 2 years
• Some short term safety but
mainly effectiveness
Phase 3 1000‐3000 1‐4 years • Safety, dosage, effectiveness
• Determine and monitor life‐cycle
Phase 4
Phase 4 Occurs post‐market
p
Varies management, safety surveillance
management safety surveillance
introduction
and adverse effects
CLINICAL TRIALS MARKET – INDIA.PPT 4
6. India is fast emerging as the most preferred destination for
clinical trials
Overview Revenues from Clinical Trials
•Clinical trial research constitutes 2/3rd of
R&D spending USD mn
•Low cost and speedy trials have made 600 500
India a preferred destination for clinical +28%
400
trials 200
•India’s share in global clinical trials 200
70
market is expected to increase from 5% 0
in 2007 to 15% in 2011 2002 2007 2010
Clinical trials phase wise India ‐2008 Number of Clinical Trials
Phase 2 Total = 536
20% 600 +143% 536
400
10% Phase 4 221
65% 2% 3% 200
Phase 1/2
Phase 3
Phase 1 0
2007 2008
CLINICAL TRIALS MARKET – INDIA.PPT 6
8. Drivers & Challenges
Challenges
Shortage of research professionals
Drivers
Lack of data exclusivity
Lack of data exclusivity
Cost competitiveness
Delays in trial approval
Vast patient population with diverse
number of diseases
number of diseases
Challenges of unethical trials
Sound medical infrastructure
International quality standards
CLINICAL TRIALS MARKET – INDIA.PPT 8
9. India offers significant cost savings in clinical trials
Cost Competitiveness Impact
• Multinational pharma companies can achieve cost savings of around 30–50% when outsourcing
clinical trial projects to India
Phase US Costs Indian Costs
Phase I USD 20 mn <USD 10 mn
Phase II USD 50 mn <USD 30 mn
Phase III USD 100 mn <USD 60 mn
• Patient recruitment lead‐time is about 30‐40% lower in India compared to the US
• In the US, it might take nearly three years to get around 100 patients to conduct trials on them,
in India the same number could be gathered in about six months
Chemist Productivity and Cost Comparison Overall Indexed Clinical Trial Costs
Hrs/Week USD Germany 1.20
80 70 UK 1.09
15,000 12,000
12 000 US 1 00
1.00
60 50 Spain 0.93
10,000 Poland 0.77
40 Australia 0.73
20 5,000 France 0.71
800 India 0.56
0 0 China 0.52
US India US India
I di Russia 0.40
0 40
CLINICAL TRIALS MARKET – INDIA.PPT 9
10. Wide spectrum of diseases makes India an ideal destination for
clinical trials
Vast patient population with diverse number of diseases Impact
• India with a population of 1 bn has a broad spectrum of diseases
• Diseases like multi‐drug resistant pneumonia, hepatitis B, diabetes and some cancers are far
more prevalent in India than in the West
l t i I di th i th W t
• Recent global guidelines make it mandatory to test new drugs across a variety of new gene pools,
making India ideal for clinical trials
Disease
Disease Number of patients
Number of patients
Asthma 40 mn
Cardiovascular Diseases 35 mn
Diabetes 34 mn
HIV/AIDS 4.2mn
Cancer 3 mn
Alzheimer’s 1.5 mn
Epileptic 8 mn
Hypertension 15% of total population
Schizophrenia 1% of total population
HIV AIDS Adult prevalence rate 0.36% of total population
CLINICAL TRIALS MARKET – INDIA.PPT 10
11. Sound medical infrastructure has made India an ideal destination
for clinical trials
Sound Medical Infrastructure Impact
• India has over a million English speaking, internationally qualified doctors, nurses, and
support staff
• India has established world‐class expertise in complex medical practices such as Cardiac care,
Cosmetic surgery, Joint replacements, Neurosurgery etc
• Medical investigations are conducted using latest diagnostic equipment meeting the
stringent requirements of FDA
Indian Healthcare Infrastructure ‐ 2006
Public Hospitals 4,049
Private Hospitals
p 11,334
,
Hospital Beds 875,000
Doctors 1,000,000
Medical Colleges 221
New Doctors every Year 18,000
Retails chemist Outlets 350,000
Dental Colleges 100
Pharma Colleges 150
CLINICAL TRIALS MARKET – INDIA.PPT 11
12. India upholds intellectual property protection as per
international standards
International Quality Standards Impact
• India became member of WTO in 1995 and agreed to adhere to the product patent regime by
2005
• Regulations passed by the government in 2005, committing itself to uphold and enforce
intellectual property protection as per international standards, has made the US and Europe to
look at the country as a preferred destination for clinical trial outsourcing
• India has been part of the many FDA and European Medicines Agency (EMEA) registration
studies
• The acceptance of data generated from India at all major conferences and journals proves its
credibility
CLINICAL TRIALS MARKET – INDIA.PPT 12
13. Shortage of research professionals and lack of data exclusivity
could hamper growth in this sector
Shortage of Research Professionals Impact
• India is facing a shortage of Good Clinical Practice (GCP) certified sites and investigators
• Over the next five years about 1,500‐2,000 good clinical practices (GCP) trained investigators
supported by 50,000 clinical research professionals would be required in India
Demand Supply Gap
CRO Staff 6,000
1,000
1 000
Other Site Staff 4,000
400 Demand
2,000 Supply
Investigator
300
Sponsor Staff 1,000
200
Lack of Data Exclusivity Impact
• Unlike the US and EU India does not provide data exclusivity in clinical trials
Unlike the US and EU, India does not provide data exclusivity in clinical trials
• Indian law has no statutory protection for the data that is submitted to regulatory authorities for
approval of any products
• Although India is a signatory to the TRIPS Agreement, no new law have been introduced to
p
protect test data
CLINICAL TRIALS MARKET – INDIA.PPT 13
14. Delays in trial approval and challenges of unethical trials can
slow down growth in this sector
Delays in trial approval Impact
• Delays in granting approvals is affecting pharmaceutical companies and CROs in India
• Delays happens as the Drugs Controller's office depends on external experts and agencies such
as Indian Council of Medical Research for advice and additional permissions required for import
of trial samples and export of blood samples to foreign laboratories
Clinical Trials Approval time
Months
10 8
5
1 1 1
0
US UK Canada India
Challenges of Unethical trials
h ll f h l l Impact
• Supreme Court of India had hauled up two top biotech companies Shanta Biotech & Biocon for
openly conducting illegal clinical trials of new drugs on unsuspecting patients after a litigation
filed by Aadar Destitute and Old People's Home (an NGO)
• NGO alleged that the two companies had conducted improper clinical trials of Streptokinnese ‐ a
new clot‐busting drug used in heart attacks without requisite permissions, as a consequence
eight people lost their lives
• Few incidents of illegal clinical trials has fueled immense concerns of a huge public outcry over
clinical trials
li i l t i l
CLINICAL TRIALS MARKET – INDIA.PPT 14
16. Trials can be initiated only after approval from Drugs Controller
General of India (DCGI)
For Approval purpose clinical trials are classified into two types
Category A
Category A Category B
Category B
• Includes clinical trials whose protocols have been
• Includes clinical trials whose protocols have been
approved in other countries which are not listed in
approved by USA, UK, Switzerland, Australia, Canada,
category A
Germany, South Africa, Japan or the EMEA
y, , p
•R l t
Regulatory (DCGI) turnaround time will be 8‐12
(DCGI) t d ti ill b 8 12
• Regulatory (DCGI) approval time is within 2‐4 weeks
weeks
• India has well‐defined guidelines for carrying out various phases of clinical trials
g g g ( )
• These guidelines are in line with the global guidelines on clinical research (ICH‐GCP)
• First time exposure of new drugs (of other countries) in Indian healthy volunteers is not allowed as per the
regulations in India
• Clinical research organizations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India
(DCGI) and import license to import the research drug
• In case samples are exported outside the country an export license is required from Directorate General of Foreign
Trade (DGFT)
• Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry‐
India (CTRI) website
CLINICAL TRIALS MARKET – INDIA.PPT 16
17. Schedule Y of the Drugs and Cosmetics Act applies to trials of
new drugs
Schedule Y of Drug and Cosmetic Act deals with regulations relating to clinical trial requirements for the
import, manufacture and obtaining marketing approval for a new drug in India
Based on marketing approval, drugs are classified into three categories
Based on marketing approval drugs are classified into three categories
New drug substances New drug substances
discovered that are already discovered that are not New drug substances
approved /marketed in other
d/ k t d i th approved/marketed in other
d/ k t d i th discovered in India
di d i I di
countries countries
• Clinical trials have to be
carried out as human
• It is sufficient if
• Permission for clinical /clinical pharmacology
confirmatory trials (phase
trials were earlier given trials (phase I)
III) are conducted to obtain
with a phase lag • The phase I trials are
data about the efficacy
• This has now being revised
This has now being revised carried out on healthy
carried out on healthy
and safety of the drug in a
• Clinical trials can now be human volunteers
large number of patients
conducted concurrently • Purpose is to determine
(minimum 100, in 3‐4
with other countries the maximum tolerated
centers)
dose in humans, adverse
reactions, etc
CLINICAL TRIALS MARKET – INDIA.PPT 17
18. ICMR guidelines seeks to ensure ethical practices and minimize
exploitation of the participants
Indian Council for Medical Research (ICMR) Guidelines for clinical trials
• The proposed trial should be carried out, only after approval of the DCGI
• Informed consent is necessary
Drug trials
Drug trials • First three of the four phases of clinical trials of drug require ethical clearance
• The duration of time lapsing between two trials in the same volunteer should be a minimum of 3 months
• The first phase should involve low risk subjects
Vaccine trials
Vaccine trials • Prophylactic vaccines are supposed to be given to normal subjects
Prophylactic vaccines are supposed to be given to normal subjects
• Therapeutic or curative vaccines may be given to patients suffering from particular diseases
Surgical • Safety data of the medical device in animals should be obtained
procedures/ • Phase I of drug trials is not necessary for trial on devices
medical devices • Safety procedures to introduce a medical device in the patient should be followed
• In human beings, for investigation and treatment, different radiations ‐ X‐ray, gamma rays etc can be used
Diagnostic agents • Radiation limits for the use of such materials and X‐rays should be in accordance with the limits set forth by the
regulatory authority (BARC) for such materials
regulatory authority (BARC) for such materials
• Safety measures should be taken to protect research subjects and others who may be exposed to radiation
• For herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System
Herbal remedies procedures laid down by DGCI for allopathic drugs should be followed
• This is not applicable for Ayurveda Siddha or Unani drugs for use in their own system or hospitals
This is not applicable for Ayurveda, Siddha or Unani drugs for use in their own system or hospitals
CLINICAL TRIALS MARKET – INDIA.PPT 18
20. Major clients for CROs are international pharmaceutical
companies
Overview
•India has over 50 CROs in clinical trials Global Pharma
•Major sponsors for clinical trials are international
M j f li i l t i l i t ti l Companies
pharmaceuticals companies with huge R&D
spending
Outsource
y g p
•Many Indian and foreign pharmaceutical
companies have tied up with other specialist Drug
research companies for development of new Clinical Trials
Discovery
drugs
•Pharma companies are leaning towards
Ph i l i t d
outsourcing and concentrating on marketing
without spending time for drug discovery and
manufacturing
•Internationally certified central laboratories and Research
CROs
research institutes also take part in clinical trials in Institutions
India
CLINICAL TRIALS MARKET – INDIA.PPT 20
21. Clinical Research Organizations (1/7)
Company Locations Business Description
AcuNova Bangalore, • Provides end‐to‐end services for Phase I ‐ IV clinical research, including Clinical
Manipal and Trial Management, Clinical Data Management, PK/PD services and Central Lab
Mangalore
• Offers services in drug discovery, medicinal chemistry, toxicology studies
Advinus Pune and • It entered into Joint venture with Johnson and Johnson subsidiary, Ortho‐
Therapeutic
Therapeutic Bangalore McNeil‐Janssen Pharmaceuticals Inc in September 2008
• It has alliances for neglected diseases with Geneva based Drugs for Neglected
Diseases initiative (DNDi) for tropical disease kala azar and anti‐malarial drugs
with Genzyme Corp and Medicines
• Offers lead generation and optimization and early computational chemistry
Aurigene Bangalore aided and design, mining and screening of novel chemical entities.
• Has worked on collaborative discovery programmes with Novo Nordisk on
Diabetes and discovery services with Rheosciences, Denmark
• Has a pipeline of 15 discovery programs at various stages
• Works in product chemistry, organic synthesis, chiral synthesis technology
Avra Labs Hyderabad • Company is focusing on high‐end contract research, custom synthesis of
complex chemicals and difficult to manufacture intermediates and APIs
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 21
22. Clinical Research Organizations (2/7)
Company Locations Business Description
• Offers services in Phase I/ II/ III/ IV clinical trials, post‐marketing surveillance,
Asian Clinical clinical data management, regulatory services
Hyderabad
Trials Limited • Entered into strategic alliance with VPSCRO, a CRO based in Beijing, China to
conduct clinical trial services in India, as well as in China in April 2008
• Bioavailability / bioequivalence, food effect, dose response, steady state, drug –
Bioserve Clinical drug interaction, special populations, pharmacoscintigraphic imaging
Research Pvt. Ltd Hyderabad • Has completed over 450 studies for various pharmaceutical sponsors
• Completed over 65, for Regulatory submission to US FDA, UK MHRA, SA MCC,
AUS TGA, WHO, Health Canada and other agencies
ClinInvent • Provides services to the pharma, biotech and medical devices industries
p ,
Mumbai • It has a tie‐up with MDS Pharma Services, a leading North American CRO
• Company plans to work on projects that involve genomics
• Has expertise in managing several clinical trials in all major therapeutic
categories
t i
Clintec
Bangalore • Its clients include pharmaceutical companies such as Abbott, Novartis, Roche
and Wyeth and major biotech companies such as Serono and Chiron
• Present in over 30 countries worldwide
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 22
23. Clinical Research Organizations (3/7)
Company Locations Business Description
ClinWorld • Provides clinical trial services, pharmaceutical and bio pharmaceutical analysis ,
Mumbai and
pre‐clinical services and regulatory services
Bangalore
• It has clients like Ciba‐Giegy, Glaxo Wellcome
• Offers services in medicinal chemistry, bioinformatics, clinical trials, custom
synthesis and drug discovery
GVK Biosciences Hyderabad • Its clients include Wyeth, Biogen, Merck & Co
• In March 2009, it got approval from Ministry of Health, Turkey for
Bioequivalence Studies
• Offers services in medicinal chemistry, custom synthesis, CRAMS
Hikal Ltd. • It has tied up with Merck and Novartis
p
Mumbai Financials
• Reported total income of USD 67 mn and operating profit of USD 13 mn in
FY2008
• Offers services in medicinal chemistry custom synthesis CRAMS
Offers services in medicinal chemistry, custom synthesis, CRAMS
Khopoli (near • Has alliance with Austin Chemical Company, US
Innovasynth
Mumbai)
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 23
24. Clinical Research Organizations (4/7)
Company Locations Business Description
• Provides services in bioinformatics, clinical trials, CRAMS, medicinal chemistry
services, custom synthesis and drug discovery service
Jubilant
J bil t
Noida • Entered into a drug development joint venture with Lily in 2008
Organosys
Financials
• Reported total income of USD 414 mn and operating profit of USD 91 mn in
FY2008
• Offers services in clinical trial management, clinical data management, bio‐
statistics, medical writing, regulatory consulting, drug safety &
Karmic
pharmacovigilance and bio‐analytical services across early to late phase (phase I
lifesciences Mumbai through IV) and pre‐clinical research
• It has strategic alliances with Strategic Capital Investments LLC and Seahorse
Scientific Services Ltd
• Clinical development (phases I to III), regulatory affairs, clinical data
Gurgaon and management, biostatistics and scientific programming, late phase, etc
Kendle
Ahmedabad • It acquired the Phase II‐IV business of Charles River Clinical Services in 2006
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 24
25. Clinical Research Organizations (5/7)
Company Locations Business Description
Lambda Ahmedabad, • Works on all aspects of clinical drug development including clinical trials, clinical
Therapeutic Mumbai and laboratory, data management, bioequivalence/bioavailability studies
Research Ltd Chennai
Lotus Labs Pvt. Bangalore • Phase I to IV clinical trials including bio equivalence studies, drug storage &
Ltd distribution, bio‐analytical and statistical services.
di t ib ti bi l ti l d t ti ti l i
• Many of Lotus Labs’ submission studies have been approved by USFDA, WHO,
EU, Canada and ANVISA
• Lotus submission studies have been submitted to over 45 countries across the
globe
Matrix Hyderabad • Offers services in Drug Discovery, Development and Commercialization of New
Laboratories Ltd Molecular Entities (NMEs)
• One of the largest Active Pharma Ingredients (API) players with over 70 drug
master files, 165 API in the market or under development
master files 165 API in the market or under development
Financials
• Reported an operating loss of USD 8333 in FY 08
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 25
26. Clinical Research Organizations (6/7)
Company Locations Business Description
Parexel Hyderabad and • Therapeutic expertise, clinical trials, data sciences, patient recruitment, medical
Bangalore writing and submission, clinical logistics services
• Operates in 69 locations throughout 52 countries around the world
• It acquired ClinPhone a leading clinical technology firm in August 2008
PharmaIntel Kolkata • Offers services in Protocol and CRF designing ,conduct s phase II and III clinical
trials , site management for clinical trials and monitoring ,clinical data
, g g,
management, post marketing surveillance study, phase IV clinical trial, medical
writing /report writing etc
• It is a part of KPC Life Solutions
PPD Mumbai and
Mumbai and • Provides services in preclinical/phase I, phase II‐III, post‐approval and labs
Provides services in preclinical/phase I, phase II III, post approval and labs
New Delhi • It entered into a strategic collaboration with Merck & Co for vaccine testing
and assay development in April 2009
Reliance Clinical Mumbai and • Offers services in preclinical services, clinical pharmacology and
Research
Research Bangalore pharmacokinetic services, clinical trial management and monitoring, diagnostic
pharmacokinetic services clinical trial management and monitoring diagnostic
Services laboratory services, pathology laboratory services
• Has conducted over 120 trials, ranging from Phase 1 studies, Phase 2 to 4
studies and bioavailability and bioequivalence studies
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 26
27. Clinical Research Organizations (7/7)
Company Locations Business Description
SIRO • Provides services in all phases of clinical trials and in all key areas of the drug
Mumbai development process
• It has acquired mid sized European CRO Omega in April 2008
• Provides broad range of clinical research services from phase I to phase IV
Synchron • It acquired Innovance, a start up CRO based in Ahmedabad in 2007
Ahmedabad
p g
• It commenced operations in Bangkok in 2007
• Has a Joint Venture with Boston‐based Parexel International
• Contract research and analytical testing, clinical lab – pathology services,
analytical testing of water, food & drugs, environmental assessment
• Vimta Labs has so far conducted more than 600 BA/BE studies and clinical
Vimta Labs has so far conducted more than 600 BA/BE studies and clinical
Vimta Labs Ltd
Hyderabad trials involving over 120 drugs
Financials
• Reported a Total Income : USD 18 mn and an Operating Profit of USD 5 mn in FY
2008
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 27
28. Clinical Research Institutes (1/3)
Institute Location Areas of Research
Advanced Centre for • At present comprises of the basic and clinical research wings and a 50‐
Treatment, Research and Mumbai bed hospital
Education in Cancer • Conducts research and development on cancer
• Design and development of drugs, diagnostics/vaccines right from the
synthesis of compounds upto regulatory studies and clinical trials
• Undertakes contractual research work
• Research activities are broadly divided into three subgroups:
Central Drug Research
Lucknow Drug discovery & development
Institute (CDRI)
Regulatory studies
Infrastructural support groups
• Developed a new drug to control and cure depression, the new drug
has been found to be safer that the existing anti‐depression drugs
• Promotes research in the field of cancers
Institute of Cytology & p y
• Institute undertakes multidisciplinary studies in order to understand
Noida
Preventive Oncology the natural history, biological behavior and mechanisms of
carcinogenesis
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 28
29. Clinical Research Institutes (2/3)
Institute Location Areas of Research
• It is a National Institutes of Health (NIH) designated unit for HIV / AIDS
National AIDS Research Clinical Trials Network
Pune
Institute • It participates in clinical trials conducted by global networks of HIV /
AIDS
New Delhi • This center is dedicated to provide infrastructure facilities and a
National Brain Research
coordinated multidisciplinary team to work at the frontiers of
Center
neuroscience
National Institute of • Conducts research on acute diarrhoeal diseases of diverse etiologies
Cholera and Enteric Kolkata as well as on typhoid fever, infective hepatitis and HIV/AIDS related
Diseases epidemiological research and screening
• The Institute specializes in advanced research addressing the basic
mechanisms involved in body's defence and host‐pathogen
National Institute of New Delhi
interactions
Immunology
• In a process of developing a vaccine to safeguard children from
diarrhea caused from rotavirus, vaccine is undergoing clinical trials
• It works under the Indian Council of Medical Research (ICMR),
National Institute of Ministry of Health and Family Welfare, Government of India
Hyderabad
Nutrition • Its clinical division offers training, advisory and consultancy services
to the government and other organizations
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 29
30. Clinical Research Institutes (3/3)
Institute Location Areas of Research
• Since 1974, it has been functioning as a WHO Collaborating Centre for
National Institute of Pune arbovirus reference and research
Virology (NIV) • NIV is also the National Monitoring Center for Influenza, Japanese
encephalitis, Rota , Measles and Hepatitis
• A WHO Collaborating Centre for TB Research and Training
• Has conducted randomized controlled clinical trials for treatment of
Tuberculosis Research both pulmonary and extra pulmonary TB in collaboration with various
Chennai
Centre (TRC) hospitals and medical colleges
• The centre functions from three campuses at Chennai, Tiruvallur and
Madurai
Note: This list is not exhaustive
CLINICAL TRIALS MARKET – INDIA.PPT 30
32. PE Investments
Date Company Private Equity firm Amount Description
30‐Apr‐2009 Karmic Life Indian Angel Network USD 500,000 The investments have been made for minority
Sciences stakes in the company
19‐Aug ‐2008 Rubicon Kotak Private Equity Undisclosed Rubicon Research is setting up a clinical trials
Research Amount supply facility in Ambernath
14‐Sep‐2007 Sai Sequoia Capital India USD 12.5 mn Sequoia Capital India has invested in Hyderabad
Advantium based Sai Advantium for 18.34% stake
26‐Jun‐2006 Siro Baring Private Equity Undisclosed Stake offloaded is less than 30 %
Clinpharm Amount
CLINICAL TRIALS MARKET – INDIA.PPT 32
34. Key Developments
Date Development
22‐Jun‐09 Switzerland‐based contract research organization PFC Pharma Focus has set up an Indian subsidiary
with the help of Excel Life Sciences, a US firm that specialises in running trials in India
15‐May‐09 GVK Biosciences, has entered into a strategic alliance with Excel Pharma Studies a Chinese research
organization, to conduct clinical trials in Asia. Both the companies will help sponsors to conduct and
manage phase II‐IV clinical trials, statistical analysis and medical writing
5 –May‐09
y Jubilant Organosys Ltd, through its Bangalore, based subsidiary, Jubilant Biosys Ltd, has signed a
g y g g y y g
research collaboration agreement with, AstraZeneca, focused on delivering novel drug candidates into
the international pharmaceutical company's pre‐clinical pipeline
10 – April‐09 Suven Life Sciences has completed its phase one multiple ascending dose study of SUVN‐502 in
healthy volunteers. SUVN‐502 is a potent, safe, highly selective, brain penetrant and orally active
antagonist at a non peripheral CNS receptor site 5‐HT6, intended for the symptomatic treatment of
t it t i h l CNS t it 5 HT6 i t d d f th t ti t t t f
Alzheimer's disease, Schizophrenia and other disorders of memory
23‐Jan‐09 Syngene, Biocon's (India) contract research firm, has signed a partnership deal with U.S. biotech firm
Sapient Discovery
9‐Jan‐09 India's Ranbaxy Laboratories Ltd commenced initial‐stage clinical trials on an experimental respiratory
I di ' R b L b i Ld di i i l li i l i l i l i
inflammation drug it which it is jointly developing with Britain's GlaxoSmithKline
29‐Sep‐08 India's Orchid Chemicals & Pharmaceuticals Ltd and U.S based Merck & Co Inc announced drug
discovery pact to develop new drugs to treat bacterial and fungal infections. Orchid's research unit,
Orchid Research Laboratories, will identify drug targets and develop them through phase II clinical
, y g g p g p
trials and Merck will conduct late‐stage clinical trials and sell the drugs after regulatory approvals
CLINICAL TRIALS MARKET – INDIA.PPT 34
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